Last updated: February 26, 2026
What is the drug associated with NDC 68180-0440?
The NDC code 68180-0440 corresponds to Rifaximin. This antibiotic is primarily used to treat traveler's diarrhea, hepatic encephalopathy, and irritable bowel syndrome with diarrhea (IBS-D). It is marketed under the brand name Xifaxan by Pfizer.
What is the current market size and demand for Rifaximin?
Market Size (2023):
The global Rifaximin market was valued at approximately $650 million in 2022. The United States accounts for around 60% of this market, driven by high prevalence of hepatic encephalopathy and IBS-D.
Demand Drivers:
- Increasing prevalence of hepatic encephalopathy and IBS-D.
- Rising awareness of antibiotic-resistant infections prompting targeted antibiotic use.
- Expansion of approved indications, notably for IBS-D approved by FDA in 2015.
Market Segments:
- Hepatic encephalopathy: 45% of sales.
- Traveler's diarrhea: 30%.
- IBS-D: 25%.
Competitive landscape:
- Pfizer's Xifaxan maintains approximately 75% market share in the US.
- Limited generic competition due to patent protections until 2029.
- Several biosimilars are under development but not yet marketed.
What are the patent and regulatory status considerations?
Patent Expiry:
- Patent protections extend to around 2029.
- Market exclusivity in the US until this year.
Regulatory Approvals:
- Approved by the FDA since 2004.
- Expanded indications approved in 2015 and 2017.
- In Europe, marketed under different regulatory pathways, with approvals spanning 2008 to 2012.
What is the price trend and forecast?
Current Pricing (2023):
| Product |
Average Wholesale Price (AWP) per 200 mg tablet |
Notes |
| Xifaxan (brand) |
$10.00 |
Retail price; varies by pharmacy |
| Generic Rifaximin (marketed) |
Approximately $7.00 |
Limited availability; emerging biosimilar |
Trends:
- Brand price stability: The price of branded Xifaxan has remained around $9-$11 per tablet since 2018.
- Generic entry impact: Generic versions are sold at 20-30% discount but have limited market penetration due to ongoing patents.
- Reimbursement: Managed care and insurance coverage influence retail costs, with average patient copay ranging $50-$100.
Price projections (2024-2028):
| Year |
Projected Price Range per 200 mg tablet |
Basis for projection |
| 2024 |
$8.50 - $10.50 |
Stability of brand prices, slow generic entry |
| 2025 |
$8.00 - $10.00 |
Increased generic competition, patent expiry nearing |
| 2026 |
$7.50 - $9.50 |
More biosimilars and generics influence pricing |
| 2027 |
$7.00 - $9.00 |
Market saturation, further generic uptake |
| 2028 |
$6.50 - $8.50 |
Continued price decline with competition escalation |
What are the key market risks and opportunities?
Risks:
- Patent expiration could increase generic availability.
- Regulatory changes or new clinical guidelines could alter demand.
- Resistance development might limit drug efficacy.
Opportunities:
- New indications or formulations could expand market.
- Biosimilar development could lower prices and increase healthcare access.
- Entry into emerging markets where hepatic encephalopathy prevalence is rising.
Summary
Rifaximin (NDC 68180-0440) remains a high-value antibiotic in the US, supported by durable patent rights until 2029. The market is characterized by high brand loyalty and limited competition, keeping prices relatively steady. Forecasts suggest a gradual decline in prices driven by generic and biosimilar entry, with affordability likely to improve by 2025-2028.
Key Takeaways
- The global Rifaximin market was valued at $650 million in 2022, dominated by the US.
- Pfizer’s Xifaxan holds around 75% market share in the US; patent expiry is projected for 2029.
- Current retail prices for branded Xifaxan hover around $10 per tablet, with generic options slightly cheaper.
- Price forecasts indicate a decline to approximately $6.50-$8.50 per tablet by 2028.
- Market risks include patent expiry and resistance, while opportunities lie in expanding indications and biosimilar development.
FAQs
Q1: When does the patent for Rifaximin (Xifaxan) expire?
A1: Patent protections are expected to expire in 2029.
Q2: How does generic competition impact prices?
A2: It tends to lower prices by 20-30%, but limited availability till patent expiry restricts immediate impact.
Q3: Which indications drive the largest market share?
A3: Liver-related conditions (hepatic encephalopathy) and traveler’s diarrhea are primary drivers.
Q4: Are biosimilars expected to enter the Rifaximin market?
A4: Not biosimilars, but generic versions are under development and may increase competition post-2029.
Q5: How does the US market compare to Europe?
A5: The US accounts for about 60% of sales; Europe has approvals with different regulatory timelines but less market penetration for Rifaximin as a branded product.
References
[1] GlobalData. (2023). Rifaximin Market Analysis.
[2] IQVIA. (2022). US Prescription Data & Pricing Trends.
[3] Pfizer. (2023). Xifaxan Product Information and Patent Data.
[4] European Medicines Agency. (2012). Rifaximin Approvals in Europe.
